Investigation Into Detection of Prostate Cancer Using Voided Urine (Prostate VPAC)

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• Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:
• Provide signed and dated informed consent form (ICF)
• Male
• Patients must be 50-70 years of age (VPAC) or 50-75 (STEAP1)
• Willing to comply with all study procedures VPAC Specific Aim 1 - Prostate Cancer, PCa (N = 150)
• Known diagnosis of untreated prostate cancer, scheduled for robotic prostatectomy
• No prior treatment (surgery, radiation, or medical therapy) Specific Aim 1.1 - Normal PSA (N = 125)
• PSA < or = 1.5 ng/ml within the last year
• No diagnosis or suspicion of cancer anywhere along the genitourinary tract
• No history of BPH Prostate VPAC Version 8.0 Protocol 20G.196 20 June 2025 Based on SKCC Interventional Protocol Template v.20170209 page 20 of 31 Specific Aim 1.2 - Benign Prostatic Hyperplasia, BPH (N = 100)
• PSA < or = 1.5 ng/ml within the last year
• Previous history of PSA >1.5 ng/ml are still eligible if they underwent surgery for the treatment of BPH and had a subsequent decrease in PSA below 1.5 ng/m
• Has a diagnosis of BPH, BOO, or LUTS Specific Aim 2 - Persistently Elevated PSA, PE (N = 100)
• Patients with a negative prostate biopsy within the last 1 year from the day of consent
• At least two elevated PSA values, defined as 2.5 ng/dL or greater, with the most recent result being within the last 1 year from the day of consent, unless otherwise approved by the PI
• HGPIN and ASAP are considered negative
• Previous biopsy results, if a repeat prostate biopsy patient, do not need to be available, there is also no preferred timeframe of previous biopsy (can be >1 year at time of consent) STEAP1 Specific Aim 1: To determine STEAPl receptor density as a function of PCa GGl to 5 using receptors specific immunohistochemistry Specific Aim 2: To determine STEAPl expression as a function of PCa GG, 1-5 using quantitative RtPCR.
  • An individual who meets any of the following criteria will be excluded from participation in this study:
• Subjects under the age of 50 or over the age of 70 (VPAC) or above 75 (STEAP1)
• Individuals with any cancers along the genitourinary tract (does not include penile or testicular cancers)
• Individuals taking finasteride or dutasteride, which decreases the PSA value
• Individuals with gross hematuria suspicious of bladder cancer